holding this hearing this morning. live coverage on c-span3.

good morning. the committee has come to order. one thing, i want to thank the

witnesses for your testimony. those appearing in person, traveling to d.c. to give it orally, and, also, answer our questions. the title of this hearing now is, i guess, examining the u.s. approach to early covid-19 treatments. i thought it was -- i originally set out a title of "early treatments for covid, a essential component of a covid solution." it was inevitable that the coronavirus pandemic to be politicized into the tragedy it was. from the start, i knew it was impossible to have a perfect response. we were facing a new virus. no one wanted to underreact, and as a result i feared the tendency would be overreact. the challenges facing us were daunting. our national strategic stockpile

had been reduced during the h1n 1 pandemic. it took time to develop a test. the fact that a large percentage of people that become infected exhibit no symptoms made the coronavirus even more difficult to detect and contain. i have tried not to criticize the elected officials that had the responsibility to make very tough decisions with limited and highly imperfect information. others have not been so reluctant. perhaps my backgrounds manufacturing taught me to be more understanding of those faced to and forced to deal with the situations. the members the committee had a front row seat to government's response at the federal and state level. we've participated in dozens of conference calls and multiple hearings with agency officials who have worked 24/7 to respond to an unprecedented event. it's always easy to criticize

but i, for one, have been sympathetic with the challenges they faced and highly appreciative of their efforts. as we are all aware, the coronavirus is not going away. even though it appears an effect i ha effective vaccine might have been developed, people will continue to become infected and sick for months to come. we still need to develop effective therapies, particularly in the very early stages of the disease. it is on this point that i have been and will continue to be highly critical of our collecti collecti collecti collective dereliction. we are all aware that the tamaflu is only effective when prescribed early enough to stop the flu virus from replicating and before the patient becomes too sick. why haven't federal agencies and the medical community applied

the same logic and approach to the coronavirus? this question has baffled me since march and there is probably not a single explanation. we do know the coronavirus was politicized and used as an effective weapon in the presidential election. we also know some suggested therapies included off the shelf supplements. the cost of these therapies is well under $50 versus a brand new drug remdesivir that costs over $3,000 and can only be used in hospital and therefore it does not prevent hospitalizations in the first place. could big pharmaceuticals played a role in less costly alternatives. i think the answer seems obvious. this hearing is not about promoting any one particular therapy over others.

by reading the testimony and watching the tweets, it may be unavoidable. i have to say the absence of any serious nih study or consideration of high driving while intoxicated color wean it is worth discussing. this is a drug that has been safely and effectively used to prevent malaria, treat lupus, and rheumatoid arthritis for decades. and doctors who had the courage to use the off-label prescription rights had been scorned. state medical boards have threatened to withdrawal their licenses. the same has happened to pharmacists filling prescriptions for the drug in some states. for those using other-the-the shelf drugs suffer the same fate? since the onset of the pandemic, i have publicly advocated for allowing doctors to be doctors.

to practice medicine. explore different therapies. share their knowledge within the medical community and with the public. i believe international, federal, and state medical allegation -- agencies and institutions let us down. i fear too many have been closed-minded bureaucrats driven by agendas. tragically, media and social media failed to ask the right questions and sensor what they do not understand. my public advocacy connected me to doctors who care and who are trying to come passionately help their patients in spite of the bureaucratic roadblocks they've encountered. over the last month, i've been included in an e-mail group comprising of over 250 practicing physicians from all over the world sharing their knowledge and experience. three members of the group are here today. to me, it's obvious we should explore every possible treatment

to combat this pandemic at every stage of the disease. why is there such resistance to low-cost, off-the-shelf therapies. i hope today's hearing can answer that question and provide correction on how to correct the blaring blunder that cost far too many lives. the personal story to make point. my first child, my daughter was born with a serious congenital heart detect. her arteries were reversed. through the first day of life, a wonderful man, dr. john thomas, came in the middle of the night and performed a action. they c.ashoved a balloon, blew

balloon open, pulled it back, and ripped a larger hole so her blood could oxygenate until she was old enough to have a surgery that occurred eight months later. with another incredibly skilled surgeon. now at the time, some people were using other options. this surgeon had developed a techniq technique to use tissue that would grow at the heart. my daughter is 37 years today, mother of two children, and nurse practitioners in a nicu, previously. we had a wonderful result because i had access to doctors and to treatments produced by previous doctors that practiced medicine. i don't think there's a random

controlled trial on that option or the rebaffling technique. these were skilled physicians practicing medicine. what i have found over the last eight or nine months in dealing with this issue, we have fewer practicing doctors and more doctors that follow protocols, which is entirely appropriate. i completely agree with practicing protocols. using random controlled trials, but there are moments in medicine, moments in our history where you have to allow doctors to practice medicine to develop these therapies. that's been the history, honestly, the development of medicine. my final point is to talk about the bill i championed through congress, right to try. now, the current situation, for example, of hyde hyde is not a prime example of right to try. it's a fully approved drug. but right to try said if a drug has gone through the first two stages of fda approval, it's

been proven safe, but it hasn't gone through the final efficacy approval, a patient and a doctor still have the right to try that if there are no other available treatments. isn't that the position we're in? there's no other treatments. i'm for allowing doctors to practice medicine to treat patients compassionately as early as possible so they don't progress into the hospital and intensive care unit. senator peters? >> thank you, mr. chairman, and

to our witnesses for being here today. we have lost more than 250,000 americans to the coronavirus. the united states is now the first country in the world to reach more than 170,000 confirmed covid cases in a single day. those numbers, unfortunately, are continuing to rise. in my home state of michigan, positivity rates rose to almost 12% and we have lost 439 michiganers to the pandemic in the last week. in order to successfully tackle this pandemic, our response must be driven by recommendations from public health officials that are rooted in science and transparency. we'll take an all-hands-on-deck approach to ensure that americans receive the most accurate information on how to protect themselves. unfortunately, misinformation and disinformation continue to run rampant. that's why i introduced

legislation to create a covid-19 disinformation and misinformation task force that would work to slow the spread of unfounded information and, in the process, save american lives. as members of congress, we also have a responsibility to ensure the information we present to the public is accurate and rooted in science. americans must be able to rely on and trust the independent food and drug administration and centers for disease control and prevention. political interference and misinformation undermines the hard work that dedicated scientists and experts are carrying out at these critical agencies. we must also be careful of giving americans a false sense of security by promoting untested and unproven outpatient remedies. we all want answers that will keep our families healthy and safe. i'm concerned many of the treatments that will be discussed today have been presented as panaceas for the coronavirus. it would be irresponsible to

give americans false hopes that these types of treatments will be enough to keep them safe in lieu of other measures that are scientifically shown to slow the spread of coronavirus. our nation's top scientists must be able to do their work without meddling to ensure that the treatments and vaccines for covid are safe and are effective. and are trusted by the american people. unfortunately, this information has continued to exert pressure on our government's top public health agencies to water down guidance and even promote unproven treatments further putting americans at risk. these actions have also diminished the publics' confidence in eventual coronavirus vaccine and treatments. from the very start of the pandemic, the president and others in the administration have consistently undermined and questioned public health experts at the food and drug

administration and the centers for disease control and prevention. they have pushed unproven treatments instead of leading by example and practicing simple measures that we know prevent the spread of the virus, like wearing mask and social distancing. we have made significant progress in the development of covid-19 treatments. those developments must be free from politics and must be driven by solid data. recent promising news from pfizer and moderna indicate their vaccines could be highly effectivin effectivin effective; however, we're waiting for further review of the data an even an approved vaccine will likely not with available for many more months. we must continue to use masks, social distancing, exact tracing, and other measures for the foreseeable future to protect our friends and our neighbors to stop the spread and ultimately to save lives.

>> thank you, mr. chairman. >> thank you, senator peters. it's the tradition of this committee to swear in the witnesses. it you'll stand and raise your right hand. do you solemnly swear that the testimony you give before the committee will be the truth, the whole truth, and nothing but the truth. so help me god. please be seated. our first witness is dr. peter mccullough. the current vice chair of internal medicine at baylor university medical center. he received his m.d. from the university of texas southwestern medical school and his m ph from the university of michigan. he's board certified american board of internal medicine and cardiovascular disease. he specializes in treatments of patients with complicated internal medical problems and affected major organs including the heart and kidneys.

>> thank you for allowing me to talk to you today about the critical need for early treatment for covid-19, as an emergency measure in the middle of this national crisis. as we sit here today, we have the greatest mass of infected americans that we've ever had since the start of the pandemic. americans are pouring into hospitals untreated. the hospitals census is already at capacity. a national calamity of unimaginable mortality is right around the corner. in a matter of weeks to months, americans are going to be horrified with what they see on the news with respect to the hospital overrun, mortality skyrocketing for both covid and noncovid complications and conditions, and patients further infecting other americans as

this pandemic spirals out of control. my viewpoint, and my view, is expressed here is my own. this pandemic should have always been viewed as having four pillars. if we can bring up the figure. the first pillar is contagion control. we've had probably the vast majority of government efforts solely focus on contagion control. the entire media representation of what the government has been doing has been on contagion control. as we see it here today, it's obvious contagion control has not solved the problem. the second pillar is early ambulatory treatment. this virus, yeah, infects individuals and they sit at home for two weeks. we have a two week opportunity to treat the problem. we hear nothing about it. we hear nothing about early ambulatory treatment. there's no updates. there's nouveau point to americans of what is going on outside the united states where early ambulatory treatment is a standard of care in countries that are doing a much better

than the united states. it's grossly overlooked. the third pillar is the hospitals. and i already told you they're overrun. we're doing the best technologies we possibly can in the hospitals but the hospital is an inadequate safety net. the current mortality rate is about 5 to 7%. patients get in the icu, it's 25%. virtually all the covid deaths occur in the hospital. it's obviously not an adequate safety net for americans. the fourth pillar is vaccination. it should bring out the close of the pandemic. this hearing is about early policewom treatment. we learned a lot about the virus. there have been over 75,000 peer-reviewed publications since the onset of the pandemic. information is flowing in the about 500-papers a day. so any expert who claims that a review of data and studies is contemporary, they're quickly out of faith. and i can tell you with had pandemic, and this virus what we've learned there's an early

viral rep indication phase. and what doctors have done is they've innovated and they've identified both in the hospital and outside of the hospital aided by clinical trials and observational studies and approach that involves combination anti-virals followed by steroids and anti-thrombosis bottic statements. doctors are faced with thousands of patients calling and begging for help have innovated doctors. there's one in new york of the middle of the calamity in new york who was an early innovator. i summarized these and published them in "the american journal of medicine" of randomized trials and observational studies and this -- umm, arlg rhythm has been updated multiple times and provides a framework for new drugs and agents to be incorporated in an early ambulatory treatment approach. i've reviewed every report from real world data from american doctors who have innovated and faced this problem.

and i can tell you they are achieving rates of hospitalization and death less than 3% for high-risk americans. most doctors can achieve less than 1%. with no treatment in the united states right now, an individual over 50 with medical problems faces the 7% rate of hospitalization and death. someone in their 80s, it skyrockets to 40%. as a doctor, i have always treated high risk patients with the best tools available. and i looked at the evidence, when it was obvious that aids drugs didn't work, i didn't use them. but hydroxycholoroquine, i combined it with other drugs and steroids. that should be noncontroversial. doctors should be using clinical steroids. they're supported by in parent and outpatient studies as well as blood thinners. what doctor would not help a patient at risk of a catastrophic stroke? i can tell you now, i'm not asking for permission do this but your help.

i'm asking for the government to organize all government agencies that are related to this to assist doctors rapidly with their innovation and their compassionate care of patients with covid-19 at home because we can prevent hospitalization and death. right now it's the only option on the table. thank you. >> thank you, doctor. our next witness is dr. harvey risch. he's a professor of epidemiology in the department of epidemiology at the public health and public health of the yale school of public health and the yale school of medicine. he received his m.d. from the university of california san dieg diego. he authored more than 325 original research publications, a member of the connecticut academy of sciences and engineering. he researched the efficacy of seven medications for the high-risk covid-19 patients in 42 hospitals across brazil. doctor? >> senators and colleagues, thank you very much for

convening this hearing. we understand the disease we're facing and that we have to face head on and not hide from it hoping it will go away. so i'm going to give you my perspective on this. in may of this year, i observed that results of studies of a drug suggested to treat covid, hydroxycholoroquine, were being misrepresented. what i thought at the time was sloppy reporting. we heard how covid disease progresses in phases from viral rep indication. it's an outpatient condition but the phenomena that fills the lungs with immune system debris and is life threatening is hospitalizeble. we've also heard how each phase, each pathologic aspect of the disease has to have its own specific treatment. how the treatments are delived from the buy logic mechanisms of the disease. i was flankly astudented that

the studies of hospital treatments were being represented as applied to outpatients in violation of what i had learned in how to treat patients in medical school. we're now finally coming to address why over the last six months our government research institutions have invested billions of dollars in expensive, patented medications and vaccine development but almost nothing in early outpatient treatments, the first line of response, to this pandemic. and it's not that we've lagged mitt indication study. we've had a number of promising agents. i think that the early on con flags of hospital with outpatient disease serve to imply that treatments of outpatient disease had been studied and found ineffective. this illogical premise motivated me to look at what actually the evidence for outpatient disease and its treatment were. so i want to reiterate that we are considering the evidence for

early treatment of high-risk outpatients to prevent hospitalization and mortality. that's it. not talking about inpatient disease. that's a totally different consideration. i'm talking only about outpatient disease. so this is treatment starting in the first five days or so after the onset of symptoms. treatment of older patients, patients with chronic conditions like diabetes or obesity, heart diseases, lung diseases, kidney diseases, immune system diseases, survivors from cancer, and so on. these are the people who are most likely to die from covid. they are the people most in need of prevention protection. in doing my research, i sought to obtain reports of every study of every medication pertaining to early treatment of high-risk outpatients. i monitored the literature daily, which is a task. and what i have found is that actually remarkable. what i've observed is that rather than positive reports of a number of drugs, every study

of the outpatient use of one particular drug, hydroxycholoroquine, with or without accompanying agents has shown substantial benefit in reducing risks of hospitalization and mortality. now these studies break down into two major types. the first is the double blinded randomized control trials that various government and scientific personalities say provide the strongest, supposedly the only trust worthy form of evidence. the second is nonrandomized but still controlled trials. there are some truth in that assertion about the nature of the quality of the evidence, but there's also much falsehood. we know, for example, that the great majority of drugs used to treat heart diseases were established before randomized control trials with nonrandomized trials. cholesterol lowering drugs were in wide spread use before randomized trials were down.

the most common antibiotic used in children was not established by randomized control trials. the great majority of drugs in use today were not established when they went into wide spread use with randomized trials. many had trials later but the establishment of use of drugs is not always done by the basis of randomized trials but the study with other kinds of studies. thus the idea that only randomized trials provide trust worthy evidence is a sim policist simplistic notion that sounds good in theory and it is what many doctors believe but the idea does not stand up to the body of medical studies and data that addresses it. in fact, we have large amounts of empirical data. dr. tom frieden, previously the

director for the centers for disease control, in 2017, wrote an extensive essaying show nonrandomized trials and randomized trials show compelling evidence for the efficacy of treatments. underline this was a huge meta analysis of meta analysis. what i call a megaanalysis done by the library con sobsortium. the conquering investigators examined what involved tens of thousands of study comparisons. this is a huge amount of data. between randomized trials and their corresponding nonrandomized counter parts. when thcompared they found they arrived at identical

conclusions. this evidence is why well performed, nonrandomized trials are every bit as much of a gold standard today as the randomized trials you've heard of. this empirical data. not opinions. what did i find when i investigated hydroxycholoroquine in early use among outpatients? all right. the first thing is, this drug is extremely safe. exceedingly safe. we know this from common sense. this is ahmed indicati medicati hundreds of years and tens of billions of doses worldwide prescribed without routine screening. it's given to adults, to children, pregnant women, nursing mothers, such a drug must be safe and must be safe when used in the initial viral replication phase of this.

and so could you please put the delaying paper and the supplement into the evidence into the record. this is a paper showing that more than 900,000 hydroxycholoroquine users that show no mortality and no increased cardiac arrhythmias. so in spite of the safety, surprisingly, in july, the fda posted a warning against the outpatient hydroxycholoroquine use on its website and they did this while at the same time the fda had no systemic evidence of adverse events in outpatients and the website itself said it justifies the warning based on evidence it had in-hospital patients and justified it for use in outpatients, which is what i said before was invalid. there are now seven studies of early use of hydroxycholoroquine in high-risk outpatients. every one of these studies has

shown significant benefit. this includes 636 outpatients in brazil, 199 clinic patients in france, 717 patients in brazil, 226 nursing home patients in marseilles, more than 1200 patients in new jersey, 100 long-term care institution patients in angora, and almost 8,000 patients across saudi arabia. all of these studies showed about a 50% or greater reduction in risk of hospitalization or death. and, in fact, the saudi study was a national study and demonstrated a five-fold reduction in mortality for hydroxycholoroquine plus zink. the two used together versus zinc and standard of care alone. an none of these studies have shown a single fatal cardiac arrhythmia.

in addition to this, there have been six outpatient randomized control trials. we've heard a lot about this. these trials individually were small and incomplete and were stopped early but together when analyzed together, as we did, they show a statistically significant reduction in risk and that's what matters. so if that paper can be entered into the record. this body of evidence for hydroxycholoroquine dramatically outweighs the risk benefit ratio for remdesivir, antibodies, and the difficulty to use them that fda has approved for emergency use authorizations while denying the emergency use authorization for hydroxycholoroquine. this is an egregious double stharnd fda did on hydroxycholoroquine that needs to be overturned immediately and the emergency use authorization application approved. i'm restating that every outpatient study of hydroxycholoroquine has shown

benefit. there are no studies, as far as i know of, as of last night, that are of high-risk use in outpatients that do not show benefit at all. so, now we spent the last six months with formal government policies and warnings against outpatient treatment, the government has invested large amounts of vaccines and expensive new treatments which have yet to be proven while there's been no support for evaluating inexpensive but useful medications. a quarter of a million americans have died from this mismanaged approach. even if we find that the vaccines eventually work effectively and safely, as we hope, myself included, people will still get sick and die and early outpatient treatment is still and will be continuing an essential part of ending this pandemic. thank you very much. >> okay. thank you, dr. risch. the next witness is dr. fareed. a medical specialist in california with over 50 years of experience in the medical field. he graduated with honors from

harvard medical school in 1970. after two decades of teaching and researching in academia, he returned to clinical medicine and established a general practice. currently the medical director and family medicine specialist at pioneer's medical center. he treated countless covid-19 patients both outpatient and inpatient. dr. fareed? >> thank you. mr. chairman, senators, and colleagues, thank you for -- >> is your mic on? >> i hope so. i know you have a different atta attachments to that. all will be entered in the record. >> thank you, mr. chairman, senators, and colleagues. i have a background in viologist, as you mentioned. academiaic background research standpoint from work at the naid as a professor performing

research at harvard medical school after i graduated from harvard in 1970, i became a professor there. later at ucla school of medicine. at about 31 years ago, i decided to go into clinical medicine, which is my passion. i chose a rural area underserved where i thought i could make a difference. and i've had experience in that 30 years treating hiv, other infectious diseases, and practicing as a primary care medicine provider and being a hospitalist. my experience is during the pandemic, treating covid patients both in the covid-flu stages as outpatients and also as hospitalized patients in the icu, made me determined to prevent the covid flu from progressing to the horrible, lonely storm suffering that i saw in the icu and i still see it. we accomplished this with what i present here today. like everything else in medicine, the goal is to treat early. covid patients are difficult to treat whether they get very

sick. the imperial valley, where we work, became the covid epicenter for california in june and july. since early march, both in my clinic and dr. brian tyson's all valley urgent care clinic, where i also work, over 25,000 fearful people were screened. over 2,400 were covid-19 positive. we treated successfully over 1,000 high-risk and symptomatic ones. the interesting thing, to me, dr. tyson and i independently came to the protocol for that purpose back in march. and we based it upon the great work from doctors -- they're our heros, actually. it was the triple hydroxycholoroquine cocktail. hcq 3200 milligrams over five days, another drug, and especially zinc which is often left out in the studies.

the cocktail is best give early, as d indicated within the five to seven days where the patient is in the flu stage. the timing of the drug is when the virus is in a max replication phase. our goal is to prevent it from entering the lower respiratory tract and prevent hospitalization. we achieved this in over a thousand patients. that was involved reevaluating them at two to three day intervals. we prolonged the treatment for five or more days if symptoms weren't but they generally did not and do not. we use it especially in the high risk individuals, as indicated. those over 50 to 60, those with cor comorbidities. we want to avoid the covid syndrome in all patients that

ha happens after they recover. i use this to treat 31 elderly nursing home residents in an outbreak in june and 29 recovered fully. the drug works through multiple actions. the it blocks the signal one receiptor and has several antibiotic effects. as additional agents become available, they can be added to this to enhance the efficacy and routinely now combining another drug, which you mentioned, chairman, in a quadruple cocktail with excellent results. since it's safe and has a different action. this becomes able gus to the use of multiple agents for hiv treatment. anti-bodies from regeneron will be suitable, also, and readedly

available. the results are consistently good. often dramatic with improvement within 48 hours. we wouldn't have stayed with this if it weren't helping people and always reliable. we've seen very few hospitalizations. we've seen not a single negative cardiac event. our experiences are in line with all the studies that the doctor mentioned. let me be clear, this is only about the science. the science of viral rep indication, the science of the stages of covid, and the science why early treatment works. and early treatment has led us to actually try to communicate our approach. we think it should be on a national level. we wrote a letter with my colleagues to the president. a letter too congressmen, a letter to the california health department, an open letter to dr. fauci, and a national plan for covid 19. as we describe in the national plan, the approach would be part of the solution to the pandemic. protect the vulnerable and, if

high risk individuals get sick, there's a solution for them with early treatment with the anti-viral cocktail. if early treatment becomes widely available, people will be much more confident going back to work and sending their kids back to school. thank you. >> thank you, doctor. our final witness. cheffed his m.d. from harvard medical school. in 2013, he was elected to national academy of medicine. a globally recognized expert on the pandemic preparedness response. lead ground-breaking research on ebola and on the front lines of covid-19. ly practices as a general

internalist in rhode island. doctor? >> good morning. chairman johnson, ranking member peters. i'm sorry i cannot be with you in person today. it's my honor to be part of this hearing. as you've heard, we are entering the most difficult days of this pandemic. so i am so pleased that the committee has met to discuss the value of outpatient therapies. treatments that can be done early in the disease course. by treating people early, we can prevent hospitalizations and save lives. the good news, withere are outpatient therapies being evaluated and we should be hopeful, i'm hopeful that some will work. one area where outpatient therapy has largely not been useful is hydroxycholoroquine. earlier in the year, the fda issued a surprising emergency use authorization for this medicine. as subsequent data came in, the eu a was revoked because it became clear that hydroxycholoroquine was unlikely to be effective for covid-19. so was the fda justified in

issuing an eua in march? i believe it was not. euas are contingent on three interrelated questions. first, is there sufficient data to even make a judgment if we have enough evidence. second, the potential benefits outweigh the risks? and, finally, will there be an opportunity to collect more data over time? for hydroxycholoroquine, there was not sufficient evidence and the evidence that was there certainly did not suggest benefits would outweigh the risks. the basis for the hydroxycholoroquine eua was some laboratory studies and really ultimately one small nonrandomized, nonblinded study of hospitalized patients in france. findings that were later discredited and the scientists who lead that work is now facing disciplinary actions. since then, dozens of studies have examined the efficacy of

hydroxycholoroquine. here is the bottom line, every single high-quality study failed to find any benefit of hydroxycholoroquine for covid-19. and i have to say, i'm disappointed. hydroxycholoroquine is a cheap and widely available medicine. had it been effective, it would have made an enormous difference. unfortunately it's not effective. and there is now clear consensus in the medical and scientific community based on overwhelming evidence that hydroxycholoroquine provides no benefit in treating covid-19. let's talk evidence. a large randomized control trial published in "the new england journal of medicine" found no benefit to hydroxycholoroquine given to outpatients who had been exposed to sars covid. the recovery trial found higher rates of death among hospitalized patients on hydroxycholoroquine. but this included people whose symptoms had begun within the past seven days.

that early phase of the disease that was talked about. other inpatient trials found similar results. there are outpatient high quality randomized double blind control trials and they have failed to find the benefit. now, dr. risch talked about observational studies and we should talk about them. can they be helpful? they can. we don't generally use them for treatments because we want high quality data but it's possible to use high quality observational studies. it requires controlled groups that are comparable and use sophisticated statistical techniques and look for things like natural experiments to help us understand whether something is likely to be useful. i'm not aware of any observational study of hydroxycholoroquine that is a particularly high quality. and for every poorly done observational study that shows benefits, we can find poorly done observational studies that show harm.

out of the low quality evidence quagmire is to generate higher quality data. it turns out that history of medicine is replete with treatments that we've all thought worked but turned out not to. antidotal evidence, it turns out, is not actually evidence. the miracles of american medicine have come from applying rigorous, scientific standards to our ideas. each time hydroxycholoroquine has been subjected to such a test, it has failed. let me make two more points, as i finish up. one, that i'm often asked by people, well, in the middle of a crisis, how can it hurt? the fda issued its eua for hydroxycholoroquine in march of this year. in april, there was a 93% increase in related calls to the u.s. poison control centers. these things can hurt. and, finally, a word about the eua process. when the fda scientists are left alone to examine the science and data, the process largely works.

they understand the urgency of the moment and the need for faster improvements but authorizing therapy due to political pressure or little to no data does far more harm than good. as a physician, i've been troubled by the plitzation of hydroxycholoroquine. it's a potential therapy. we should study it. if it works, we should use it. if it doesn't, we shouldn't. but i have to be honest, give the dismal failure of hydroxycholoroquine to date, there is little scientific basis to think it will be effective for anybody. at this point in the pandemic, with so much suffering and death, we should focus our efforts on promising approaches to help americans get through the crisis. thank you very much. >> thank you, doctor. i said in the hoping statement, i kind of figured it was going to not necessarily as broad of a discussion based on other early treatments and we're going to get into dispute on hydroxycholoroquine. so i guess so be it. obviously, we have a huge disconnect between testimony here. between experts.

you know, harvard and yale-educated doctors and ph.d.s. i know the 93% increase in poison reportings sounds pretty scary. you mentioned before the hearing a little bit about what it is based on. can you talk about that? also, i guess you've had covid. you've recovered from it. not totally. you testified negative so don't represent a danger but can you, first of all, talk about the 93% increase in safety or in poison reportings and, also, just talk about your own personal experience with your own treatment. >> senator, i want my testimony to clearly be on the record that i think the doctor's testimony is reckless and dangerous for the nation. his comment regarding the poison control reporting is exactly what dr. peters is interested in. you're interested in misinformation regarding covid.

that report, in the middle of the pandemic, when hydroxycholoroquine early on was appropriately used, first wave of the pandemic, that kept it from skyrocketing. hydroxycholoroquine was widely used early on. that's what kept the march, april, may curve down. okay. when it was used, and we had 500,000 dose administrations of hydroxycholoroquine, the poison control center received, i think the number was 77 additional calls. when the reviewer looked at it, two-thirds of them, somebody took an exto dose and they were concerned. it boiled down to 17 cases out of over 500,000 administrations yet dr. ji holds that up to the american public as a scare point. it scare the public away from a safe and effective therapy for covid-19. as you mentioned, i had it myself. i'm 57. i've got asthma. i've got cardiovascular disease. i can tell you, senator peters,

i was not falsely reassured sitting at home. believe me, when i got that test result, i was terrified. every american is terrified. every older patient with heart and lung disease, when they get the report, they're not falsely reassured and sit at home and think this is going to be a picnic, they are scared to death and by the time they come to the hospital it is frank terror. they know they'll be isolated and never see their family members again. what did i do? i did the right thing. i got myself rapidly into an fda approved treatment protocol through a study, hard to dosh by the way, because the government offers no resources to the public to get into clinical trials, i got into it, took hydroxychloroquine as part of a multi-drug sequence program, the framework of how americans should be treated. well, i was a few days behind in recognizing what was going on. the virus got into my lungs. i had pulmonary involvement.

i got anxious. i got to the point where i thought maybe i could be hospitalized and i can tell you firsthand this cocktail of drugs works for sure but hydroxychloroquine settles down the fever, reduces the intensity of symptoms and that's why it reduces hospitalizations and death. when patients get anxious and they can't breathe anymore they go to the hospital. so this isn't complicated. the studies are all supportive. when the epa says it shows safety, we ought to go and we these to go with this on everybody high risk in america. >> dr. rish, when you listen to dr. jha, sounds very authoritative. do you have a response? >> yes, thank you.

i think that what i said early on about the conflation of hospital without patient studies is apparent, that there's been lots of studies, and there's no doubt that there are plenty of hospital studies, and some of those hospital studies, indeed, show no benefit, if not harm, and there are reasons for that, and i don't want to get into the technical issues, and -- of these studies but just to say it's irrelevant. studies of hospital patients are irrelevant. we are considering outpatient disease and outpatient treatment. treatment that starts in the first five days. there are only seven studies, now dr. jha says oh well these are not high quality studies but, in fact, they are high quality studies. these are controlled studies. they're tantamount to randomized except that the patients chose whether to take the medications or not, with consulting with their doctors. now, you may say, well, couldn't that lead to biases? but the answer to that is, yes, but the bias is that when patients are sick they're more

likely to take the medication they're offered and when not quite as sick, and they know they've got the virus they'll say i'll see how it goes and maybe i won't have to take the medications. you have a built-in bias to doing worse. despite the built-in bias the patients do better. the studies in brazil and various other studies all though that the bias there is against finding a benefit of the drugs, and inspite of that bias the studies show benefit of the drugs. furthermore, these studies all measure all of the different variables about the state of the patients, both on the conditions, the chronic conditions that they have, about the progression of their illness, and so on, that reflects how likely they are to be hospitalized, or not, independent of the drug. and the studies address that by what we call statistical adjustment. these studies, we're not back in

19 50 doing epidemiology, we're back in 2020 doing epidemiology where we know all of the advance statistics and all the methods for removing potential biases in these kinds of studies. these are the studies that were done and how they were analyzed. and these are what studies show the benefit and these are the studies, the kinds of studies that the cochrean library consortium compared in tens of thousands of studies or modern epidemiological studies compared those kinds of studies to randomized trials and showed no difference. you can't label these studies as poor quality studies and give a blanket on that if you want to say a study in particular is poor, as the original study of 40 patients in marseilles was, that no one is now including, that was a motivating study but not an evidential study. that there's no one is claiming these are poor studies. these are good, modern studies. and the only difference is the

randomization which, instead we adjust for and have shown by the cochrean analysis that they are equivalent to randomized trials. >> okay, we do need to stay on time. my seven minutes are up. i do want to quickly go to dr. fareed. i would ask the witnesses to watch the clock as you're answering questions as well to stay in time. but just very quickly, dr. fareed, do you believe you put any of your patients at risk by treating them the way you have? i mean, as a doctor who looks at patients with compassion, do you believe it would have been better for you to do nothing and just send your patients home with no treatment whatsoever? hopefully to survive this without having to go in the hospital? can you kind of comment on that? >> i am concerned for safety of my patients, and i've not ever wanted to put any patient at risk and i've -- was concerned early of slightly, but not very much because of the results i had researched and my colleague

also. dr. tyson had taken the same approach. so the answer to your question is that i have no qualms, no concern whatsoever. i'm very pleased to put the patient on the protocol and to enhance it with the other agents that we can blend in because i know they'll get better and they are so appreciative, it's very gratifying, quite frankly, it's almost like being -- i treat hiv patients and it's been very gratifying to treat hiv patients because they can go into complete remission. when i started it was a full blown epidemic and people were dying right and left. but now, for covid-19, i'm happy to get a call from kansas or somewhere elsewhere the doctors are not providing them with treatment, and to immediately call it in because i know it's safe, and it's only going to help. >> thank you. and, again, i believe patients,

americans have the right to try these things that have already been fda approved. dr. peters -- i mean senator peters. >> thank you, mr. chairman. a number of questions for dr. jha. since the start of this pandemic there have been reports of pressure by this white house on both the cdc and the fda to influence what should be independent evidence-based public health decisions. so dr. jha, my first question is, what impact does political interference have on our nation's ability to effectively respond to a health emergency? >> yes, senator peters, thank you for that question, you know, science has always been bipartisan. and we've seen the scientific agencies, the food and drug administration, the cdc, be safeguarded from politicization

under president obama and president bush. we believe and we know that the american people benefit when the best scientific minds apply their expertise to the problems at hand. and i believe that in each of those administrations, you could disagree with policy ideas but the fundamental underlying scientific work of those agencies was always left intact. that has been different in this administration. we have seen the cdc pressured not to speak out about things where the evidence is very clear on certain issues. we've seen the fda be pressured around emergency use authorizations, for instance, what happened with convalescent plasma with dr. steven haun going to the white house and saying things that were clearly not accurate and everybody in the medical community knew they were not accurate, was baffling. it was upsetting because through my inter medical career saying something like this is fda approved was a gold standard.

it menant it had gone through a rigorous scientific review and passed the review. i believe politicization of our agencies has made it less effective and one of the reasons why america has one of the worst responses in the world with 250,000 americans dead and more than 11 million americans infected with this virus. >> dr. jha, last month i released a report on the development and the distribution of covid-19 vaccines, which found that the administration's politicization of the covid-19 response that you've just referred to has actually contributed to a sharp, sharp decline in americans' receptiveness to an eventually vaccine. my question to you, dr. jha, would you agree to that conclusion and what can the federal government do to rebuild trust and ensure americans can

feel confident that any vaccine authorized or approved by the fda is one that they should feel comfortable taking? >> i would like to talk about the whole vaccine process, which i think has been done extremely well, overseen by this white house, and i think the science behind what has happened, the partnership between the federal government and academia and industry has been a model for how we should behave. so on one hand i think that has been terrific. i think what has gotten us into a bit of trouble in the last couple of months is as election time was nearing you started hearing political leaders talk about having a vaccine before the election, or pressures to get the vaccine out before the election. i think that created a real concern among the american people that we were not going to use a scientific timeline, but a political timeline, to make a decision. i think the fda, again, has done

a very good job. they laid out criteria for what they would need to see before they would authorize a vaccine, and when those criteria are met, i expect that the fda will authorize vaccines. ultimately, if we want to build confidence with the american people, whether you're a democrat or a republican, liberal or conservative, what you want to know is are scientists getting to evaluate the data and make scientific recommendations free of political pressure, from any side of the political aisle? and if we can let the fda do that, i think it will go a long way towards building confidence in this vaccine. >> dr. jha, misinformation and disinformation surrounding covid-19 treatments, and vaccine runs rampant across the internet. americans clearly need to have clear information about treatments that have been scientifically shown, and to put the emphasis on scientifically shown to benefit patients and

certainly not unproven remedies so that you can find on the internet. that's why i introduced the covid-19 misinformation and disinformation task force. and my question to you, dr. jha, is what impact does false and misleading information about covid-19 treatments have on the american public? >> yes, senator peters, this has been a huge challenge. we are facing the biggest global health crisis of a century and it has been compounded substantially by the sheer amount of misinformation and disinformation that is out there. in order for us to have gotten through this pandemic without suffering the staggering losses we have suffered, what we needed was collective action. what we needed was people pulling in the same direction. guided by science and evidence. but when we have had things like politicization of mask wearing, we know that there is now very compelling evidence that if people wear masks in the right

setting it can make a very big difference. we know that social distancing can make a big difference in reducing infections, we know that testing and tracing can work, we've seen it in parts of the u.s., we've seen it in other countries, but the misinformation makes it harder for people to know what is right and what is wrong. makes it harder for people to know what the right thing to do is and that has really created a problem for us as an american people to do the things that will keep our population safe. and the impact is obvious. the impact is, you know, 11 million americans infected, 250,000 americans dead, and right now we are in the worst phase of the pandemic. we can get out of this. we have more than enough capability and capacity as an american people, but the misinformation is really what's killing us at this point. >> dr. jha, while the fda has released four emergency authorizations for covid-19 one has since been rescinded and another criticized as premature

due to weak data. the decision-making process for issuing these emergency youth authorizations lack transparency. do you believe the fda's eua process is working as intended, and what potential reforms should we consider? >> yes, so the eua mechanism is really important. in an emergency you don't need nor do you want to necessarily wait for full approval that you might under non-emergency circumstances. whenever you lower the bar of evidence, whenever you use an alternative mechanism, in order to build confidence with the american people, because at the end of the day it's all about confidence. it's all about trust. what you need is a process that is transparent. what i believe we need to hear is less from the political appointees and more from career scientists, and what we need is very clear criteria. and i think if those are things, those are guiding principles

that we use, i have no doubt we can build back all of the confidence that has been lost in the fda, in the cdc, in other agencies. but we've got to go back to that. it's worked for us for a very long time, and we have to go back to first principles of transparency, openness and letting the scientists doing the talking and letting the scientists do the decision-making. >> thank you, dr. jha, appreciate it, thank you, mr. chairman. >> senator romney. >> is senator romney no longer on? senator carper. i'll just go down the list. senator hassen.

okay, is everybody on that call? there is a -- just to let the witnesses know, there's a -- langford's available? >> yes. >> i'll go to senator langford. >> mr. chairman, thank you for all the witnesses, i appreciate it very much your engagement, and for the work on this. there are obviously lots of questions just on process. we have every confidence that there's work being done both in the science community and in the private sector and in the federal side. and quite frankly quite a few states as well trying to do what they can to help in the process. the challenge that we have right now is trying to be able to get all these things happening at once, it's been a remarkable year for these things to be able to move. much of what we've talked about today a an area that has not been discussed next. that is, what can be done in the earliest phases of a virus, any virus, at this point covid-19, sars 2, to be able to help diminish its effects or its

replication. we've talked a lot about how to protect each other wearing a mask, a good idea, washing hands, all these things, a lot of research is going on on the mortality side, and the hospital, blood thickening, and inflammation and organs, all those things, but it's the in between and i appreciate the dialogue about the in between at this point. what i'd like to be able to talk about with the physicians that are here is just taking a normal virus, what would you recommend for cold and flu season, whatever it may be, that individuals should take to help their bodies fight off a normal virus and then add to that what would be in addition to in particular what we'd gain from this virus as well as we go through this, that's something that has -- i just don't think there's been enough research and conversation about those two aspects, so i'd be interested in all of our physicians answering those questions, i think that's the key issue, what is typical for a normal virus and what's helpful to help the body fight off a virus in your own system

to fight it off and what are we finding helpful, even if it's only a little bit, what are we finding helpful with this particular virus? i'll let everybody take it in any order they want to take that in. >> sir, dr. mcculloch. >> thank you for the question, senator, we should narrow the question to serious and potential, fatal viral infections, so acute hiv, which is an acute, serious problem, three to five drugs, three to five drugs. hepatitis c, three drugs, four drugs. even shingles, acute shingles, which can be a real painful problem later on, two drugs. but the principle is, always early. i can't think of a single viral infection where the best advice is to wait two weeks before we start treatment in the hospital. that's the current nih recommendations. americans are appalled by this. we always treat serious viral infections with multiple drugs up front early. these are principles of

treatment. >> dr. risch quickly. >> i'd like to defer to dr. fareed, i think, on this. >> that's a great question. it's, i believe, important for people to be proactive to -- we've learned a lot of what's good to help protect people from covid-19. and -- excuse me. we've recommended, and what we've recommended to the general population where i practice is applicable to helping protect against other viral infections at this time, like influenza, and that is a good strong multivitamin, particularly zinc, supplement 15 to 25 milligrams a day. vitamin d 3, 2,000 to 5,000 units a day, and an ant oxidant

like quercitin, helpful for anti-cancer purposes too. but beyond that, i think that i've learned so much from use of the cocktail, the hydroxychloroquine cocktail that i'm convinced that it is a broad spectrum anti viral that's so well tolerated. i see patients now that are acutely ill, they look like they're covid-19, i treat them, they get better in 24 # houhourd then they're covid negative so they've had some other virus, so we've learned a lot about the value of broad spectrum anti-viral that's well tolerated. and i'm a proponent of even making it useful for influenza. >> dr. jha -- >> senator, it's jha.

>> that's what i thought. do you want to chime in on this? >> thank you for your question. anti-vies anti-virals are tough, as opposed to anti bacterial therapy, anti-virals took us about 15 years to develop anti-virals that were really effective for hiv and a long time to develop them for hepatitis c and b. and we don't have good ones for most outpatient viruses. if you think about the common cold which thankfully isn't fatal but can make you feel lousy for a couple days, we don't have good treatments for those things outside of supportive therapy like tylenol or other things that help manage the symptoms. they are difficult to develop. i think we all agree, and there's no question on this panel or among the entire medical community, that finding early therapies for sars-cov-2, the virus that causes covid-19

is absolutely critical. it would make an enormous difference and i had actually been early on hopeful that hydroxychloroquine might be one of those things. it would change the course of this disease. it just hasn't panned out the and there is a lot of work going on, there are a lot of things being studied and i think we should continue studying them. when the evidence says something works we should use it, when it doesn't, we shouldn't. >> that's very helpful. one more quick question in the minute i have left here. there's a lot of hope out there because of the vaccines that are coming, we have two vaccines on the horizon, quickly, that could be here by the end of the year, with fda -- pending fda final approval in this process, for more in the cue -- queue at this point. be scared because this was a fast developed vaccine because you should be frightened of it, and i don't see that. i'm pleased there's been no

shortcut in the science and the process on this, it's gone through all the studies and such on it. does anyone have any concern on the vaccines coming at all, that they have not gone through the proper science? >> i will say absence of a response means nobody has a concern. >> that's what i would take that as well, and i'm pleased to be able to hear that and i look forward to those vaccines actually coming to market and us moving forward in the days ahead. gentlemen, thank you for your opinions, i appreciate your insight. >> senator carper. >> mr. chairman, ranking member peters, colleagues and to our guests today, we thank you all for joining us, thank you for what you do. about eight months ago, almost to the day, our president said these words. he said it's going to disappear one day.

it's like a miracle. it will disappear. that was earlier this year. and since that time we've suffered the loss of 250,000 people in this country as of this week, 250,000. somebody's mother, father, grandmother, grandfather, aunt, uncle, child, nephew, niece, 250,000 of them. i have -- my colleagues have heard me say this rhetorical question, compared to what? well, compared to taiwan, and south korea, 498, compared to singapore, 28 #, compared to new zealand, 25, compared to australia, 907. japan, 1,908. compared to china, 4,500. india, 132,000.

canada, 11,000, 11,000. mexico, 99,000. we add all those numbers up, we've actually suffered more deaths beginning this year from coronavirus and all those other countries combined. more than four times of the number of men and women who died in the vietnam war, more than four times. and this is a -- it's been all year long it's been an opportunity for us to -- instead of being divided about this, arguing, we ought to have done a better job of figuring out how to deal with it and we should be guided by science. every now and then i hear a song on the radio, one hit wonder, thomas dolby, his one hit was she blinded me with science. and i've always said we ought to be -- not blinded by science, but guided by science. and as we hear today there's --

on science, unfortunately. there's one thing we can agree on, we need a vaccine and we need it badly, a couple vaccines if at all possible and for them to work we need to be able to reach out to people who are afraid to take any vaccine, including the two that are 95% effective. we need to be able to get the message to the american people in the weeks and months to come so that when the vaccine is available, people will take it. half the people in this country say they wouldn't take it. we have to make sure when it's available in great quantities, that almost everyone will be willing to take it. the second thing that we need to do is to figure out, with a country of 300 million people living in it, how do we get the vaccine distributed and administered to the people most in need? how do we need to make sure that they not just get one shot, but they get two shots? how do we do that and keep track and do it in a way that

increases the confidence of the american people? i would suggest, as interesting as this hearing is today, what i think, mr. chairman, ranking member, i would just urge us to focus the hearing on maybe december, certainly in january, that actually focuses on how do we actually convince the american people that the vaccines are going to be safe, that they ought to take them, and that the second thing, how do we figure out the distribution system? to be able to administer the vaccine successfully and quickly. >> i want to ask a question, if i could, of dr. j ha. not a big name, people must struggle with it. great to see you. dr. jha, you've talked about today, the need to detail vaccine distribution plans, in

public education campaigns, to universally high vaccine -- among americans, referred to that. what steps do we need to take now to ensure the states have what they need and financial logistical and technological support to provide covid-19 vaccines to every american who wants to be vaccinated? >> yeah, senator carper, thank you for that really important question. this pandemic is going to come to an end in 2021, or let us just say we will bring it under control in 2021 and we will do it through highly effective vaccines, if they are widely distributed and accepted by the american people. because the old line that vaccines don't save lives, vaccinations do, and there are many steps between a vaccine becoming available, and americans getting vaccinated. i think there are two broad sets of issues that really need addressing, first is getting states ready to receive the

vaccines, to distribute the vaccines, to have a clear game plan for who gets it first, who gets it second, what the protocols are going to be and how it's going to be distributed. those are critical issues. i'm talking to state health departments around the country and there's a lot of confusion and lack of clarity about exactly how all of this is going to work. i think that needs to be dealt with effectively soon, yesterday would have been a good day, today's better. we've got to get going on that. but the other part that goes beyond distribution is the communicating with the american people about this, and i think where the other panelists and i may disagree about the value of science and scientific evidence for hydroxychloroquine we all agree, everybody i know agrees that the scientific process behind the vaccines has been done with incredible integrity. and we've had to communicate that to the american people. we've got to bring in trusted voices, religious leaders, society leaders, political leaders to voice that

information. and help people understand, and answer their questions about the vaccine, if we do all of that, i believe that americans will be open to getting vaccinated and most will step up to be vaccinated. >> dr. jha, follow-on question, populations are understandably skeptical about government run campaigns, mass vaccinations, surveys indicate lower populations illustrate high hesitancy of white americans. how should federal state and local governments work with these minority communities to improve awareness and accept stance of potential vaccines. >> this is a critical issue, is that right. there's a long history of distrust born out of some very, very troubling practices, that have been directed towards minority communities. so these areas of concern are not born out of nothing. i believe that the best way to engage members of communities of

color is through direct sharing of information, through openness and transparency, and through engagement of trusted voices. because while the message is important, the messenger is every bit as much so. and so that does mean in my mind reaching out to religious leaders and political and society leaders in those communities, working through the evidence and data with them so they feel comfortable becoming advocates. of course we have to still do other things like make sure that we deal with financial barriers and eliminate them, and other logistical things to make it easier but it's really a combination of both those logistical financial issues but also really getting trusted voices to address this. >> mr. chairman, to the ranking member, thank you for convening us here, thanks very much for those responses. i would again urge us, maybe as early as next month, to begin a series of hearings that focus on communicating, messaging, to particularly populations that

are reluctant to take the vaccine. half the people in this country say they're not going to take any vaccines, we've got a lot of work to do. >> senator carper, i'm happy -- >> a lot of people to distribute to, that's a lot of work to do and we need to work together. >> senator carper, you know, appreciate your questioning here. i'm happy to hold a follow-on hearing, i'm happy to schedule it right away but i will say, i've heard it said repeatedly. we've got to convince the american public that the vaccines are safe. i don't recall anybody on my side of the aisle questioning the safety of the vaccine process. that seems to have been coming from elected officials on the other side of the aisle in your presidential candidate. if we have to repair the damage of the credibility of the vaccine it's not because of what republicans have said, sorry i didn't say partisan. but with what folks on your side of the aisle have said. >> this is not a democrat versus republican issue. >> you made it that. >> we've got to work together, that's all i'm saying.

>> thank you, mr. chair, just checking my sound, can everybody hear me? >> yes. >> loud and clear. >> thank you. thank you, and thanks to our witnesses for being here today, thanks to the chairman and ranking member peters for holding this hearing but i would like to just start by expressing my deep concern over the president's decision to fire director krebs of the cybersecurity agency. director krebs and his cybersecurity team helped protected our election from cyberthreats and moreover they did an admirable job of fighting the plague of disinformation that sought to undermine our election process, the bedrock of democracy. director kreb's leadership is to be commended and his firing is unwarranted and it makes our country less safe. the director's firing and the future of ciso would be a more appropriate topic for a hearing

in this committee than what we are focusing on today. now, turning to the topic of today's hearing, over the past two weeks we have received encouraging news of potentially promising vaccine candidates. however, even under the best circumstances, researchers suggest that a vaccine will not be widely available until mid-2021. covid-19 infections, hospitalizations, and deaths throughout the country have skyrocketed and experts agree that we have a very difficult winter ahead of us. the senate should encourage people to make evidence-based decisions about treatment, and take precautions to keep themselves and their families safe, such as practicing social distancing and wearing masks. so i have two questions to dr. jha. first, dr. jha, as we learn more about how covid-19 is transmitted in communities across the country, it's becoming increasingly clear that small gatherings with friends

and families are driving much of the spread we are currently seeing. it's understandable that people feel comfortable gathering with friends and family who they know and they trust, but i'm concerned that americans are not getting the information that they need to fully assess risks associated with these types of gatherings. so, doctor, can you talk specifically about why it appears that these smaller types of gatherings have been such a driver of community spread, and what steps people should be taking to reverse this trend? >> senator hassan, thank you for that question, and this is, in fact, a really troubling issue because of course we are at a -- more than 150,000 infections a day, hospitals are really starting to get full and when you look at where a lot of the spread is happening, as you've said, senator, a lot of it is happening in people's homes. the reason is what we know about this virus at this point is that spread happens when people gather indoors, and are not wearing masks.

that's the major risk factor for spread. now, it's been a long pandemic already, and a lot of people are tired, and there is a sense that your home is your safe place. i understand that sense. but when you invite friends and family, you, again, make the assumption that they are safe. and i understand that. the problem is that there is so much sasymptomatic spread of ths virus, so many people who spread the virus without feeling any symptoms at all, when you bring friends over, you get together, you have a meal, you share some drinks, and eventually obviously the masks come off and people get close because those are natural patterns that feel normal to us and that has become a major source of spread of this virus leading to a lot of infections and deaths. beyond better communication, under, you know, really stopping the disinformation and stopping the undermining of science, i think at this point the critical issues really are about telling people where the risks are, and

helping people make better decisions. this is not forever. this is really for the next few months until we have a vaccine. >> well, thank you. i want to follow up on this, the risks associated with the pandemic have led millions of americans to make the difficult decision to adjust thanksgiving celebrations and other holiday gatherings. many others, however, are still struggling to determine whether there's a way to travel or celebrate safely. so what advice do you have for those who remain uncertain about whether to travel over the thanksgiving holiday? >> yeah, senator, this is one i have struggled with myself, you know, during thanksgiving we usually get together, either with my in-laws or my own elderly parents. and i thought a lot about, is there a way to do it safely? and i've concluded, i can't figure out how to do that safely. as much as i would love to see my family, for thanksgiving, i also want them around in 2021 and i believe that household gatherings, of people who are not part of your family, don't

live at home with you, is just very, very hard to do safely right now. and so i have come to the unfortunate conclusion that i'm recommending to people that people not do that. they can get together outdoors, if that's possible, go for walks, spend time outdoors with masks. but indoor gatherings, a traditional thanksgiving family meal, don't know how to do that safely this year. >> my family is making similar determinations, the usual group of 30 of us who gather is not going to be what we're doing this year. let me follow up with you, for those who will be hosting gatherings, if they do feel it's necessary for some reason, what specific accommodations and modifications to their normal plans do you believe are essential to help mitigate the risk of transmission over the holidays? >> yeah, so there are things that can be done to lower the risk. again, in some places of the country it may be possible to do it outside and that would make an enormous difference. keeping the number of people minimum, or small, would be

helpful. if you can keep windows open, have people wearing masks most of the time, sit somewhat separate for meals, none of this feels like a normal thanksgiving, but this is not a normal thanksgiving. we're in the worst pandemic in a century and the key here is while we want to enjoy a normal thanksgiving what we really want is our family and friends around in 2021 so we can celebrate with them once the pandemic really gets under control. >> well, thank you for that, and thank you for your work and your advice. my family will be zooming while we eat, which is our way of -- our way of sharing the meal. but thank you again for all you're doing to help keep americans informed and safe, and mr. chair i yield the rest of my time, thank you. >> thank you, senator hassan. dr. mcculloch is going to be recognized. >> senators, listening to that last exchange of questions and answers, i want my testimony to be clear.

this entire hearing was about early treatment and what those last set of exchanges showed, a complete lack of focus, it went over to the vaccine, and then it wandered over to wearing masks and even what's being offered at the thanksgiving dinner. one of the reasons why america is failing colossally is a lack of focus exemplified by the last set of exchanges. >> mr. chair, i would say that it's critically important that accurate information get out to the american people about what the best science tells us about avoiding getting the disease in the first place and taking precautions to keep our loved ones safe, that was the purpose of my questions. i thank you for holding this hearing. >> i've heard the term disinformation thrown around in this hearing a lot. i know oftentimes those accusing somebody of doing something are even more guilty of doing exactly what they're accusing others of.

i'll use the disinformation as an example. i was accused repeatedly of accepting and then disseminating russian disinformation. i did no such thing. completely false allegation. when, in fact, it was senator peters, and his staff, that introduced russian disinformation into our investigatory records. i get tired of hearing all the accusations coming from the other side, you know, on the credibility of the vaccine, it's not republicans that are questioning the validity of the science on the vaccines, the credibility of it, it's democrats. and i need to put that on the record. senator enzi. >> thank you, mr. chairman, and thank you very much for holding this hearing, it's a different hearing than anything that i've seen, and critically needed. dr. jha, i want to thank you for the positive comments about the speed of the process for a vaccine. we seldom hear that. we never hear that from the other side.

when the media wants a person to fail, there's a little recourse. and if this had happened in a non-election year, it might be totally different. politics has played a role in this. one of my first introductions to any kind of a pandemic was with a.i.d.s., and i remember president bush shocking all of us at a state of the union speech when he said, you know, we're going to spend $15 billion to solve the problem of a.i.d.s. in africa and around the world. now, back then $15 billion was a lot of money, not anymore. but as a result i got to be involved in that process. and after it passed the house and the senate unanimously, unamended, they sent me to africa to see what the problem was. i got to meet with some traditional healers.

we'd probably call them medicine men. most powerful person in the tribe because they can poison the chief and do their own autopsy. but i asked them what they learned about a.i.d.s. and they said, well, we now know that we shouldn't bleed two people with the same knife. i don't think bleeding people was an acceptable method of solving the problems of the people that were infected. but at any rate, if this had happened in a non-election year i think it would have been different. i really appreciate you holding a hearing on what people can do when they first find out that maybe they're infected. that's always when we tried to do something, even with critical things like cancer, early treatment has been important. we haven't had any discussions on early treatment. i appreciate all this information on early treatment. some of it works, some of it

doesn't, that's with everything that we know about when you get sick. some of it works, some of it doesn't. but when people are thinking that maybe they're going to die, they'd like to have some kind of a solution. they'd be willing to try some things. but obviously good news doesn't sell because you won't see it anywhere. and people aren't looking for next year's answer, they're looking for this year's answer. and, yes, they're trying to figure out how they can get together for thanksgiving. my family's trying to figure that out. and i see a real state of panic, mostly because they think that until the vaccine comes out there is no answer. so thank you for answers of what can be done. and as far as studies, i -- actual use is probably a pretty

good study. and dr. fareed, could you repeat once more what this cocktail is that you've been using, and what the results have been? >> yeah, i'd be happy to. the cocktail developed from the work of dr. raul in salonco that were our heroes consists of hydroxychloroquine. the actual algorithm now that is promulgated by the american association of family -- of physicians and surgeons presents the details. but our cocktail may be a little bit different and there's flexibility. it consists of hydroxychloroquine that we found 100% effective, 3200 milligrams over a five-day period, and then docksy -- azit ro my sin, and

zinc, we've been giving a high dose but it's very well tolerated. 50 milligrams three times a day for that five-day period. that's it, it's simple, and it's extremely well tolerated. >> how can people get these early intervention drugs? are they strictly prescription? are they -- how would you go about it? how would you get your doctor to prescribe it? >> the doctor prescribes hydroxychloroquine, and there's a growing acceptance among pharmacies to dispense it. there was quite a problem early on because of the stigma that was applied to it and misunderstandings. but in any case the hoi droksy chloroquine is a prescription agent in the united states. in other countries it's over the counter. and there are countries now that are dispensing packets that they take home that they provide off the shelf to contain all the

components, including this ivramectin, another attractive agent for anti-covid purposes. if they don't have the hydroxychloroquine, they can take the quercitin or egcg, anti-oxidants that bring it into the cell, that's an anti-viral treatment, one of them, but the quercitin, 500 milligrams three times a day during the acute infection but it's much more effective using the agent that has multiple actions as an anti-viral hydroxychloroquine. >> mr. mcculloch, would you be willing to provide us with a copy of that chart that you have and comment on this? >> the word science has been used multiple times in the hearing. in medicine we have a fair scientific process of vetting and that's called peer-reviewed

publication. what i'm holding up is a peer-reviewed publication of a treatment algorithm that was fully vetted by a journal listed in the national library of medicine, the first was in the american journal of medicine and this updated version will appear in the baylor -- medical center. this is the best available science and as a doctor, the accumulation of a doctor's career on science is actually their publication record. and at this hearing i hold the senior publication record. dr. have jha, the minority witn has never published on a treatment to covid-19 at home. in addition to dr. fareed, because you look like you're older and maybe a patient in my practice as a cardiologist. in addition to what he mentioned you would get to the second or third levels of the protocol,

which would involve the use of steroids as well as blood thinners. for my patients who have heart or lung disease, kidney disease, who are ill, typically in their 70s and 80s, it's going to involve four prescription drugs, all of which have from the scientific evidence. and the hearing is a call for not just a small group of innovative doctors and researchers, but for the broad medical community. we've got a million doctors and half a million nurse practitioners sitting on the sidelines right now. the patients are calling them. saying we don't know what to do, we don't treat covid. we're building up to mass panic in the united states. i don't hear a sense of urgency on this committee call at all. we are weeks away from mass panic and massive mortality. people are talking about thanksgiving dinner, come on, in the next -- there are so many infected people now, labs are hitting 20% positive rates. that means the number of people coming to the lab that are testing positive is 20%.

and the average person infects many more people. this is a massive calamity that's right around the corner and i'm asking, i'm pleading for the senate and america right now, in between administrations, which is a very vulnerable time, to not absolutely get clobbered with a tsunami of mortality, particularly for our elder citizens. >> i know i've run over, but i think i'm the last person. so i'd like to ask dr. risch a question. >> senator, you're not the last person. >> i realize that, but i'll give him another minute here. >> sorry. dr. risch, is there any of these kind of studies about the effect of blood thinners, if people are on blood thinners already, do they have less incidents of having covid? >> that's an interesting

question. i'm not familiar with studies of existing patients. i have seen study -- one hospital-based study of a difference in benefit between regular heparin as an anti coagulant and another drug anoxaperin, showing two-thirds reduction in mortality. it's promising to look at. i don't know whether it would be useful in regular use as outpatients. the clotting mechanism is complicated in covid. and we're not really fully on top of it and so we try a number of different medications for anti coagulation, including aspirin. >> i can follow up on that and just enter into the record billett et al., 2020. 3625 patients who were treated with low heparin or novel anti coagulant drugs there was a 50% relative risk reduction for

mortality. so blood thinners in high risk patients, in fact we've published on this, there is a stratification that we can identify who is more likely to need these blood thinners and they are older patients with heart and lung disease, and there's a dramatic benefit. so early sequence multidrug therapy is not all about hydroxychloroquine and it's not all about the virus it's handling the complications that the virus creates. >> could i just -- >> thank you all, in our protocol we start the patient on three -- on aspirin at the beginning, 325 milligram every day and that's found to be very helpful for prevention of coagulation problems. >> thank you all for your positive answers. >> senator enzi, thanks for attending the hearing. and you know, as i have spoken in conference, i've been pushing early intervention, early treatment. whatever it is, whatever works, because to me that was going to always be the key component of ending this covid crisis, and we've ignored it.

and it's baffled me, and i'll just point out, again, maybe part of the reason is the hydroxychloroquine cocktail, it's about $20, right, certainly no more than $50. remdesivir, and we'll talk about that a little bit later in terms of the side effects of that and the studies, the science behind that, costs over $3,000. could that maybe be one of the reasons why all the effort is put on these more exotic therapeutics that cost thousands of dollars versus something that's off the shelf that cost $20? something to consider. senator rosen. >> thank you, mr. chairman, and i want to thank all the physicians here for the -- i know that your dedication, the reason you went into medicine, your dedication and care and commitment to your patients and to their recovery is -- i can hear it, i can feel it and i'm happy for the robust discussion. but one thing that i would like to bring up that i think is key

to possible early treatment is robust testing. and so i want to talk about our at-home testing options. because this could be a critical component before you wait to have some more difficult symptoms. does covid-19, like you said spreading rapidly, about to hit the holiday season, highly contagious disease, we need to do more at a federal level to support testing, prevention and the treatment options, and some things that we can deliver at home that perhaps you can then be on the lookout if your symptoms begin to get more difficult or if you have some other underlying, of course, comorbidities that may contribute to your bad outcome for this disease. dr. jha, could you speak to -- please speak to how widely available a rapid at-home test might change the way that people

access tests and how it might change the way that doctors can do early intervention, depending on whether you have cardiac issues or other issues, asthma, whatever that may be, we know fda just announced this week of the prescription at home test, it's positive news but how close are we to other types of saliva tests that people might be able to give themselves over the counter, and help us get treatment for everyone, dr. jha. >> senator rosen, thank you for that really important question. there are many things we could have really done to change the trajectory of this pandemic and would have been if we could have made widespread home testing available. if those tests were available it would allow themselves to be quarantined so they wouldn't be infecting others and allowed people to seek yoeearly therapi. early treatment is only possible if you get an early diagnosis

and our testing infrastructure really is no longer managing to be able to provide that. now, i'm hearten by the luciraeua from the fda, it's one -- it's really the first true home test and it's months before it's widely available and it's going to be prescription only. what many of us have been calling for is new technologies emerging and available that would allow for widespread availability of home tests that would make a tremendous difference and they would be much, much cheaper. that hasn't happened, i believe we have the technology to do it and we need those tests but that's going to be a critical part of controlling this pandemic. >> another thing that i want to talk about as far as treatment, but treatment also takes health care workers, right? across the medical spectrum for

people who administer the test, read the tests, analyze it, f technicians and highly skilled physicians. i want to talk about our health care capacity, our role of our caregivers in their -- in this mix and so i know i have a lot of bipartisan bills that provide tax credits, training and support, on caregivers and others that also support increasing our medical infrastructure, provider shortages, like our conrad 30 program, extra gme slots, federal funding for rural areas to improve nursing. so of course all of this, more tools in the tool box, many people we see our health care system kind of buckling under. and so what kind of investments would you hope that we might put forward in a future covid package to support training across a medical spectrum to deliver vaccines and treatments

and services and all of that, because you can't do it without support, right, pharmacists, you name it. so if you could address that, i think that's also key too. >> so senator rosen, absolutely, the health care system we often think about it as hospitals and doctor's offices, and pharmacies, but what it really is, is nurses and doctors and pharmacists, who work in these places. and, in fact, one of the things i've been very worried about is we're not paying enough attention to the health care workforce right now. for instance, when we think about hospital capacity in the middle of this surge, we often say, well, that hospital has plenty of beds available. those beds aren't going to do anybody any good if there isn't a nurse to take care of a patient in that bed, if there isn't a physician to take care of that picture. we have not been paying enough attention to health care workers. that point is absolutely critical and i think finding ways of supporting them, obviously, a critical thing is we need to make sure they're protected through ppes. but there are more things that we could be doing. and then when i think about the

distribution challenges, we've all talked about the incredible vaccine that is are coming, and the importance of getting them out quickly, we're going to want to vaccinate hundreds of millions of americans over the next six months. they're going to have to be done in all sorts of places, including pharmacies, including doctor ice offices, hospitals, we have to find ways of training and supporting these workers who can actually deliver these kinds of services. so in any package that supports the health care system, thinking about the health care workers first, and then really making sure they're getting what they need is central to the success of such a package. >> thank you. i have about a minute left. i'm trying to think about all the support systems for early detection, for treatment, for vaccines, whatever that is, i also think about, in our community, my community, and of course communities across the country, families are struggling economically and that means increased food insecurity, and

those other kinds of existential things that families need in order to stay healthy, even to get to a doctor in case they don't have health care, they've lost their job. we have our food banks, our three square food bank of nevada, united ways across the country doing that and so can you talk about some of the things that people should be able to do in their home? we talk about whether maybe vitamin supplements, other things that people might take? they're not even able to purchase those if they don't have a job, might not even be able to put food on the table, that cribs to bad health outcomes too, speak about that. >> i'll say, senator rosen, that a critical part of this response, is getting people through this time period. we've seen very, very long lines at food banks. we've seen people going to work in dangerous situations because they don't have any choice, because they've got to put food on the table and in the middle of the biggest public health crisis of a century i think all

of us agree that helping people through this time period, we're not talking about forever, we're not talking about for years, we're really now talking about the next three to six months as the critical period, making sure people have enough food, making sure people are -- have access to health care, those are central, because if they -- if people don't, people are going to make tough choices that will make the whole pandemic worse and really leave everybody worse off, certainly leave those individuals worse off so any comprehensive strategy on pandemic preparedness and response needs to take into issue exactly the ones you have laid out. >> well, thank you, i appreciate your indulgence, mr. chairman, i've gone over my time as well, but i'd like to think of it, we don't live in a vacuum, so there's other things that are going to help us succeed and i want to be sure that we look at those, so whatever treatments are bright, whatever vaccines what we're prepared to have everyone get them and be able to get through this pandemic

together as a country. thank you. >> thank you, senator rosen. i've got a number of questions that i'll continue to ask. i think, you know, the point about testing, i think everybody agrees would have been great to have, you know, hundreds of millions of tests available day one but it's just not practical. it didn't happen. this isn't star trek where you just say, computer, 300 million tests. it's taken time. what didn't necessarily have to take time was using off the shelf drugs for early treatment. but yet somehow, i guess it's because president trump allowed the word hydroxychloroquine to flow off his -- out of his mouth, all the sudden that was attacked and that was poisoned and we never, ever had the nih, cdc, fda put their full weight behind an investigation of that. you know, the full clinical trials, i was pushing, i was pushing for that, not pushing hydroxychloroquine, pushing for the science. for studies. but it never happened because,

again, it was censored. we talk about disinformation. you know, not providing the public information is disinformation as well. so, again, where i fault the agencies is because they turned a blind eye toward simple, cheap, possibly effective treatments. that by the way created no harm. dr. risch, i think you mentioned, and i'll -- i've got a lot to go over here. you mentioned that the -- i guess the non-randomized trials, i guess we call that observational studies, real world experience, really involving thousands of patients, indicated that there was a 50% reduction in hospitalization deaths in the saudi arabian study, five-time reduction.

now, let's just assume that that's true. i think we can also take a look at the billions of doses a year that are prescribed of hydroxychloroquine. you know, any member of congress that's gone to africa, they've just been handed hoi droksy chloroquine as an anti-ma larrial. we treat lupus or rheumatoid arthritis. we don't give ekgs before that. the studies i saw early on were designed to fail, late in treatment were people were going to die or when their heart was already affected by the virus, of course hydroxychloroquine does have an impact on arrhythmia at that late stage, but not early. it was being recommended for early use, first five days. when you take a look at the risk reward, now that these other observational, nonrandomized trials, or studies have been conducted, 50% or five fold reduction in death and

hospitalization, versus the almost infan tis malrisk -- this has made no sense to me whatsoever. the only explanation is the politicization of it, i said that in my opening comments. i received a letter and an article by dr. steven hatfield, the letter explains what i've known about whistle blower dr. rick bright, asked by his spoor yours to work on establishing an fda expanded access investigational new drug protocol but his insubordination b -- he wednesday to janet woodcocr by people in the fda to -- he dramatically restricted

the use of hydroxychloroquine, only in hospital when i think we all recognize it's not particularly effective, possibly dangerous and only out of the national stockpile. he knew what he was doing. that's what poisoned the well, that's what created what i would call the prescription log jam here on hydroxychloroquine or early -- and i think it affected all early treatment options. it took them off the table. we took our eye off the ball. that's why i say our agencies failed us. these individuals and these agencies failed us. here's a question for you, dr. mcculloch, you mentioned this, the circle of empathy. can you talk about how you described that to me before the hearing. >> let me say before i answer that, this is not just a government culpability and malfeasance with respect to hydroxychloroquine, this is academic malfeasance, there were two fraudulent papers, one in

the new england journal of medicine, published by individuals interested in doing evil to the world with respect to a beneficial treatment of hydroxychloroquine in an unprecedented manner these two manuscripts were withdrawn after two weeks where they could scare the public and the world's physician audience. since that time there have been dozens of fraudulent -- >> reemphasize that, they were then withdrawn. >> they were withdrawn and the new england journal of medicine and lancet acknowledged they were fraudulent papers, scare papers to scare people on hydroxychloroquine. since that time there's been dozens of pile-on scare tactics in the government, this is people in my field of academic medicine, committing academic fraud. i reviewed a paper that made it into medical literature demonstrating that hydroxychloroquine causes a

heart attack, causes a giant scar in the heart. i can tell you i'm at baylor in dallas, we have the world's most recognized cardio logic program -- our senior has held more hearts in his hands. i can tell you firsthand hydroxychloroquine does not cause giant scars in the heart. so academic medicine is committing fraud. it's committing a -- i think a crime against humanity, there must be a motivation behind this that's much bigger than just democrat versus republican. i am extremely concerned, honestly, about the academic contribution to scare tactics in the world, now it's working everywhere. in india it's given firstline, such a crowded country, i've been there myself, their deaths per million is a tiny fraction of america. >> 95 versus over 700 and they're using hydroxychloroquine. >> we have nearly 800 deaths per

million population in the united states and we're all spread out. in india, they're on top of each other, less than a hundred deaths per million. the leading doctor in india is willing to come testify to the united states and tell you the reason why, they have tons of covid, it's spreading out like crazy but they're treating at home with hydroxychloroquine and other drugs, it's a multi-drug program, four or so drugs and supplements. greece is not a third world country, first line, you're given hydroxychloroquine. we've missed the ball. 30 countries have approved an oral version of remdesivir, 30 countries, including japan, every country that is actually having a reasonable public health response is treating this problem at home. now, none of these drugs are a cure, but they allow the patient to get through the illness, like myself, i missed ten days off of work, and i returned to the workforce, i didn't get in the hospital for four weeks. they allow people to stay at

home, and not go out and contaminate other people. my wife and i got it at the same time. and because we were treated at home we were able to stay at home so we didn't contaminate other people. the current program that's supported by the minority witness, the national institutes of health and all government bodies is that patients go home, get no help whatsoever, doctors are not supposed to treat them, they go out in a panic to urgent cares and they're hospitalized and die. america has to wake up right here, right now, we are getting buried and we need home treatment. >> dr. jha, let me jump in, dr. mcculloch, vice chairman of medicine at baylor, i believe harvard trained. drft harvey risch, yale, fareed, harvard trained, completely different assessment, than what you talk about, and you say it with a great deal of authority.

let me first say, what is your opinion of these three gentlemen in front of us, these three doctors? i mean, no -- i'm not -- this is not pejorative to you three gentlemen, do you think they're just idiots? again, you are very authoritative and completely refuting what these three gentlemen are talking about. this is the disconnect, and this is what america needs to evaluate. okay? so tell me what your opinion of these three gentlemen are here. >> yeah, senator johnson, i don't know these three gentlemen, they're all clearly well qualified, clearly smart. and i believe they're all clearly committed to the right issues. i have no reasons to doubt any of that. my problem here is not so much that we have a differing reading of the literature, which we clearly do, it is this idea that there is this broad conspiracy across, you know, hundreds of thousands of doctors, the nih, the cdc, all academic

institutions, the infectious disease society of america, we're all in on this conspiracy to prevent americans from getting a life-saving therapy. as you might imagine, pulling off a conspiracy like that would be extremely difficult. doctors in academics are way too disorganized to pull off such a thing. >> i never used the word conspiracy. okay. >> i understand. >> quit using that word. >> okay, fair enough. sorry. >> something has happened where we have not devoted any time or energy or resources to doing what could have stopped this covid crisis very quickly and that's called early intervention, early treatment. >> heari agree, i will not use word conspiracy, i apologize if that was offensive. i didn't mean it to be. the point is, we have tried, there are ongoing randomized control trials of outpatient therapy. and what i have said literally from march, when this issue first came up, and i've had a

long track record on this, is i hope this works, i pray it works. if it works, it's going to make a massive difference. the literature on this, it's not like no one has studied this, we've had multiple randomized trials, including some in the outpatient setting. they haven't worked. >> but, again, that is -- so, okay, i got -- that's disputed. in your testimony you came up, and i'm telling you, this is -- i would consider disinformation and a scare tactic, 93% increase in reports of poisoning and you heard dr. mcculloch talking about a half million people that took hydroxychloroquine, another 77 called in and about two-thirds of that was because they thought they maybe took an extra dose and they were concerned about it. again, you use a scare tactic of saying 93% increase in poison of hydroxychloroquine, when it's not even -- it's an infan test

malimpact. major impact in terms of your communication. >> can i have a chance to respond to that? first of all i have never ahead the claim the problem with hydroxychloroquine -- >> you marride the claim it was unsafe if your testimony. >> i didn't mention the 93%. i could have mentioned the fact that there have been more than 76,000 incidents of toxicity in the middle of the pandemic. every drug has some safety issues, including hydroxychloroquine. if it's effective we should use it. to me that is not the most compelling issue. most of my testimony was about the effectiveness. yes i did throw in a statistic which turns out to be correct and you could use others. we shouldn't focus excessively on that. we should focus on the fact that the evidence so far is very clear that therapy doesn't work if future data show that it does i will be delighted and be the first to promote it, but i've

got to be driven by the data and the science and not what i hope is to be true. >> well, again, there's a real dispute by the four members of this panel, i realize i selected three, and gary peters, senator peters selected you, but there's a real dispute, and by the way these aren't the only three people that -- take a look at the potential risk/reward ratio here, take a look at the observational success, you know, the firsthand knowledge of treating people with success, and realize, you know, really the risk/reward ratio would be in favor of give it a shot and let me make this point and i'll turn it over to senator peters, he's back on screen here, i think me, as a human being, as an american citizen, with the freedom, with a bill that i helped pass, now right to try, should have the right to access this, without the interference of bureaucrats in the cdc, nih and the fda, and that is exactly what's happened. i can't get it.

millions of americans can't access it because of the disinformation, the scare mongering, and the prescription log jam that has been created by bureaucrats. so you can sit back and go, oh, but it's -- you know, it hasn't been proven effective. well, they've never pushed trials to really analyze it and i've got some eminent people in front of me that have looked at the observational data and completely dispute that. sit there with the authoritative voice that you possibly have but we've got gentlemen here that are treating patients, within that empathy circle, and they completely disagree with you, turn it over to senator peters. i guess he dropped off. dr. jha, you want to respond to that? >> yeah, i do, sir. look, i think you can say, well, i disagree with dr. risch and we have a disagreement. the way i generally tend to

adjudicate these things, so i will read the literature and i will form an opinion. but one of the questions i ask myself is am i missing the boat on this, it's always possible any one of us can be wrong. at that point i look to consensus opinion on experts, for instance on infectious disease issues like this, go to the infectious disease society of america, they are made up of leading infectious disease experts. they do not recommend it for covid-19 and against it for inpatient therapy. i will turn to agencies like the national academy of medicine, i will turn to the national institutes for health, i will listen to people like dr. francis collins. the point is that the idea is that these are all individuals with incredible expertise looking at the data. could it be that i am wrong and dr. risch is right, sure, people can disagree but when you look at the broad consensus in the american scientific community, basically the scientific

consensus is very clear that hydroxychloroquine is not effective. now, when we have looked at it in the outpatient setting and i started with this in my testimony. we don't have great data. a small number of studies but the west one of those show it doesn't work. could we get better data? absolutely. senator, i would love it if you would push for better quality randomized -- >> i have, i have, and they wouldn't do them. okay, i've had a direct pipeline to dr. haun, and i cannot get them to do it. which, again, begs the question, why not? this has been an enormous dereliction. you can maybe turn to those different places, but as a patient, myself, i wanted to get hydroxychloroquine and i couldn't get it. okay? i think i should have the right to try, in dealing with my doctor, who i trust, who i trust, i'm sorry, more than some of these people who are so

outside the circle of empathy, and for whatever reason, again, i'm sorry it's just me. i question the fact that because this cocktail costs about $20, and remdesivir costs $3,000, that maybe there's a little bias. maybe there's a little conflict, maybe there's a little agenda that's outside of really what's treating a patient when you're in the ivory tower and you're not dealing with sick and dying and ventilated patients. so now i want to talk about remdesivir. on the three of you here. talk about what the study was on remdesivir, how strong of science that is, and what kind of dangerous side effects remdesivir causes and yet that's the drug that's been pushed, that's the one that got the emergency use authorization. whichever one of you that feels you're most qualified. >> i'll make a few comments.

to just say that with any one of these randomized trials, even remdesivir, in my view, my judgment of the evidence is that they're all inconclusive. so if you look at remdesivir, in many of the inpatient studies, do you know what the end point that they use? they actually use an end point that the physician decides, the physician decides how much oxygen the patient needs. if the patient changes in a grade of oxygen, they change on an ordinal scale. the entire randomized pharmaceutical complex right now is basically corrupt. the data on remdesivir are mixed but i just had a patient die last week, you know, receive remdesivir. the difficulty is, it's too toxic. it causes liver toxicity. the drug is administered too late. the virus was replicating two weeks ago. by the time he got into the hospital the virus has done its

job. it's a fools errand to test a single drug like remdesivir late in the illness. this is no different than hiv. we need multiple drugs yefrl up front and the best we have right now are these mixes of vitamins, supplements and then the generic medications, the best we have. the nih has oral drugs that they're sponsoring with pharmaceutical trials to move forward. if there's an oral drug tomorrow that can fit into a treatment protocol, it's red do i to go, we can plug it right in, the nih and biopharmaceuticals right now have delivered zero oral medications to doctors in practice, zero, that's our batting average right now, for all the science we've put into this as a country with the greatest pharmaceutical countries in the world, zero oral drugs were the next patient who gets sick with covid-19. >> isn't it also true that the study being conducted on remdesivir, very late in the trial, showing no improvement in terms of reducing deaths, but it

was showing improving in terms of hospital days that they actually switched the outcome, that they were going to judge the -- >> there's so many flaws to the clin call trials that people are looking to, one of the rules is, we never change the primary end point. the second rule is, we have an objective end point. the number of days someone stays in the hospital is not objective. that's determined by whether or not the patient feels like they're ready to go home, social delays and everything else. so none of these trials, none of the trials, minority witness says he wants to use the word evidence, evidence, evidence. listen, we're in a crisis. we need both the art and the science of medicine. what these doctors are telling you and the what the real world evidence is telling you is that patients using this multi-drug approach at home is the only schans to reduce authorization. remdesivir doesn't prevent hospitalization because you have to be in the hospital to get it. >> one thing i disagree with, dr. jha, the workforce issues.

the hospitals currently aren't overwhelmed but they may based on the uptick, the surge in cases, but the biggest problem they have in hospitals is they don't have the workforce. which, again, speaks to, had we really put our -- and focused on early treatment, prophylaxis, you might have a more ready workforce, you've got nurses and doctors who have to stay home, schools are closing, take care of their kids, we have not, from my standpoint, done a very good job of really addressing this in a logical way. you know, just talking -- it's got to be testing and now vaccine. we are missing to me, the key ingredient, to solving this crisis, which is early effective treatment. we ought to be pouring billions of dollars but because of the scare tactics on hydroxychloroquine. why haven't we done the studies? we scared people away from participating in the trials in

the u.s. they've tried to do is a study and they couldn't get people participating. dr. risch, can you talk again, the difference between a random controlled trial, and a non-random, or just observational studies, or just real world experience? and the validity of all? >> so, let me start with the last point, real world experience, after i published my paper in the american journal of epidemiology in may i got emails from a number of clinicians across the country saying they'd been using hydroxychloroquine very effectively. now, the criticism of that is those people cherry picked themselves to tell me that they were doing well and all the people who weren't doing well didn't report it and they didn't tell me. so i said to two of them, okay, why don't you go back, keep doing what you're doing and i'll follow up with you in a month or six weeks and see how you've done after that, so we're no longer cherry picking, we're setting them as, test candidates for their treatment plans and

after about six weeks i went back, this was dr. zelenko in new york and dr. proctor in texas and after six weeks i found dr. zelenko treated another 400 patients and had no deaths in those. another 400 high-risk patients, he's treated 3,000 patients now, 400 patients since the first time i talked to him and no deaths. and dr. proctor had 180 patients subsequent to when i first talked to him, and one death in that. their real world evidence is such that no rational person would say, i'm not going to go to them, if i get sick they're the first person i can go to, they've proved they can do this. whatever it is they're doing they're magic, it's working and they're saving their patients. >> real quick, one death, death from covid, not from hydroxychloroquine. >> it was actually not even clear it was a death from covid. the person had a heart attack out of the blue that was unrelated, it was two weeks

past, had finished all the treatment and so he wasn't even sure whether it was related to covid. but he put there to be conservative, he put it in. not even clear. it was an elderly man. that's the first thing. the second part about real world evidence and nonrandomized trials is, the only benefit of a randomized trial is if there are some unknown variables that you can't control for, all the known things that you can measure on people, you can adjust for in your study, you can match on in the study and you can remove them for bias. so that you can have a pure treatment between the people who take the drug and the people who don't. it's only the unknown variables, and the reason why these non-randomized but controlled studies have converged to randomized ones is we've learned enough about the diseases that we've studied that we know what else to measure by and large in every one of them and so we measure everything in the world and we control for them. and that has removed the

so-called unknowns of bias. and this is why there's a difference in non-randomized trials now compared to in the 1950s when we didn't know enough about what to measure and how to control for it. and so that's the second issue that the empeerically we know that nonrandomized well controlled trials work as well as randomized ones. >> dr. proctor's data are submitted and fully under the peer reviewed process, his spectacular outcomes in suburban dallas as dr. risch mentioned. >> i want to talk about the practice of medicine versus following protocols. we all agree. if you've got a scientifically based random controlled trial protocol on treating people you do it but not every human body is the same, not every person is the same and they don't all react to those protocols. even with a well established

protocol, doctors have to shift to the art and practice of medicine, correct? and particularly in an epidemic, dr. fareed, can you talk a little bit more from layman's terms about how medicine, how medicine has advanced, based on just doctors being doctors, and practicing medicine, and in an emergency where world war ii is penicillin, the cholesterol lowering drugs, how those doctors using their training, seeing a drug that can do something that with this drug for improved use over here, it just might work over here, or i've got a patient where the protocol is not working, i've got to try something. i want to save this patient's life. can you talk about as a practicing physician how you approach those situations? >> yes, i'd -- that's so important, particularly when you're on the front line and

you -- it was a war, we were at war in this pandemic and -- my colleague and i took an aggressive approach. it implied using the art of medicine, the principles that we'd learned. and i learned those principles 50 years ago. and i was lucky to have gone to harvard. i wonder if dr. jha actually treats patients, actually the way he talks. but regardless, the issue that i've found to be so important in all my years of practice is to be adaptable to bring in approaches that i'm recommended from other people that -- and other examples of where there has been a benefit, if it requires an hiv modifying a cocktail to be more effective for a patient to be continually suppressed or in the covid situation, we've continually

found our treatment, this zelenko type treatment to be very effective and reliable and we adapt it. when i'm in the hospital seeing patients come in, i don't immediately put them on remdesivir. if it's a mild type of pneumonia that they have i actually will respectful of the options that may be there and use an art in their approach. >> so dr. jha, do you want to respond? >> i spent the last 20 years taking care of veterans in the va health care system and recently switched from the boston va to the providence pa. but as a practicing physician, i

think a lot about the evidence. i think my patients want me to give them science-based treatments. obviously, every pisht is different. obviously, every single time i see a patient, i do think about how to make adjustments but i'm guided by the science or evidence. if there is no science or evidence on something and i'm going to think of an off-label use, i'm very careful on that. the history of medicine is one of often doing more harm than good. my first oath was to do no harm. and i'm very much driven by that. i started off by saying all three of these gentlemen strike me as smart and committed and caring. i would appreciate a similar sort of respect back. i do take care of my patients, and try to do my best, obviously i'm not perfect but i use science to guide me. >> have you treated any covid

patients? >> i have not, sir. >> in and i believe you talked to dr. ro and dr. slinco and refer today them as heroes. i'm adr. roh in france is now being prosecuted? >> evidently. and that is so inappropriate because he's a high-caliber esteemed doctor in tropical medicine and infectious diseases and his dedication to his patients is impeccable. he guided me. i can only credit him for leading me in the right direction and dr. tyson in our area. so these are men that will be accoladed incredibly when this is all over. >> these been prosecuting now for using a drug that's been ank 65 years being prescribed safely without ekgs, dr. mg cullen? >> i'm in close communication for there worldwide disaster with many countries. i can tell you i did a program

with ayman mathisson of the covid network in australia to show you how off-kilter the world is. in queensland, australia, a doctor will be put in jail for prescribing hydroxychloroquine. india, they give it to you right away. greece -- >> it's over the counter in some countries, right? >> my point is, we're all the way from -- they give it first line in their guidelines. but in queensland, you get put in jail. in the united states we're caught up in this flurry of data and confusion. something is going very wrong in this world. >> have i was contacted by a doctor who i think had written four prescriptions for hydroxychloroquine, four. and she was issued a grand jury subpoena by the homeland security investigation department, if you can believe that. a doctor prescribing around approved drug, and she gets a

grand jury subpoena. something is not right about that, okay. because i checked into it, they withdrew that subpoena. but there's something that has gone wrong here. there's something that is not right. and i, for one, intend to get to the bottom of it. again, gentlemen, all of you, dr. jha, all of you, thank you for being doctors. i mean that sincerely. people who have dedicated your lives to help save other people's lives. it's something to be celebrated. it's not -- you shouldn't be persecuted because you're driving to save lives because for whatever reason, there's been some politicalization of a particular drug that's been around 65 years. there's something wrong here. but i want to thank all of you for being doctors. i want to thank you for your testimony. i hope people pay attention to this hearing. again, i'm not pushing one drug over the other. what i'm pushing for is robust

studies and investigation into early treatment of covid so we can prevent deaths, we can prevent hospitalization. i'm for letting doctors be doctors and practice medicine and have the courage, when there's no other options, and let's face it, right now for early treatment, there's no other option. i think it is inhumane to basically tell somebody who is fearful and justifiably so, i tested positive for covid. is my oxygen level going to drop below 94? can i do nothing to try to prevent that? i can't try a drug that's been prescribed 65 years? i don't have the right to do that in some states? i just think that's unconscionable. it makes no sense. the risk/reward ratio is so in favor of giving these things a shot. when i had tested positive because i had one episode of afib, my cardiologist talked me

out of using hydroxychloroquine. so i used zinc and vitamin d and c. i never developed a symptom. maybe i'm just one of those lucky 40%. i'll tell you though, if i developed symptoms, would i have called a doctor and called up one of you and tried hydroxychloroquine. from what i know, i think the risk is so unbelievably low, even though i have afib, i would have tried it because i didn't want to go into the hospital. he most americans if they know about things, think rationally about things, are going to want some type of treatment. again, with that i just want to thank all of you for being doctors, for putting yourself on the line. you will be criticized. i will be criticized. we're going to be raked over social media. we will probably be censored. doctor, the video describing what you did as part of a trial was pulled off youtube and we

helped you get back on youtube. there's something going on here. i hope the american public listens. i hope they pay attention and i hope -- i hope we end up developing early treatment for covid so we can get this behind us. we're all sick of it. we want cures, we want therapies and vaccine. but we can't wait for the vaccine. we've got to take action now. thank you all. hearing rec will remain open for 15 days until december 4th at 5:00 p.m. for statements and additions to the record. this hearing is adjourned.

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the trump campaign will give an update on their election legal challenges. we hear from the president's attorney rudy giuliani. live coverage from the republican national committee headquarters in washington, d.c. gets under way at 12:00 eastern on c-span3, online at cspan.org or you can listen with the free c-span radio app. week nights this month we're featuring american history tv programs as a preview of what's available every weekend on c-span3. tonight caroline wood newhall discusses black prisoners of war and the confederacy. she talks about the treatment of those prisoners and how many were enslaved, including those born free in the north. watch tonight at 8:00 eastern and enjoy american history tv every weekend on c-span3. brendan buck joins us now, former press secretary to john boehner and speaker of the ho